The FDA Alerts Parents and Caregivers Concerning LittleOak Baby Formula


On September 14, 2023, The U.S. Food and Drug Administration (FDA) announced an alert warning parents and caregivers regarding LittleOak infant formulas, which the company is voluntarily recalling, due to nonsubmission of the FDA-required premarket notification. Because of this issue the formula; has been marketed in the U.S. illegally.

Premarket notifications for new baby formula are planned to confirm the safety and nutritive adequateness of the formula by providing the FDA the chance to review key facts regarding ingredients in the product, key nutritional information, and manufacturing data, Furthermore, before the formula is available long-term on the U.S. market. It is prohibited to introduce into U.S. commerce a new baby formula without submitting a premarket notification to The U.S. Food and Drug Administration.

By Anita Johnson-Brown

Photo courtesy of the FDA

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